Quick blog this time. Over the past several years, we have seen more and more requests from our pharmacy members looking for “Comprehensive Safe Medications Practices” or “Medication Safety Practices.” These requests are typically arising during the credentialing process with PBMs. In general, the PBMs are looking for how you ensure the medication you are dispensing is “safe” for the patient. Ultimately safe medication practices start before you even order the medication from the wholesaler/manufacturer and end at the point the patient receives the correct medication, including:
- Ordering, Receiving, and Storing Medication
- Inventory Review
- Pharmacy Management System
- Patient Information
- Prescription Intake, Review, and Pharmacist Check
- Quality-related events
In the following sections, we will discuss these areas to help you better understand what the PBMs may be asking. While all of these should really be standard practices in pharmacy, and you are probably already doing them, it is essential to understand that the PBMs may ask for your Policies and Procedures addressing these areas.
Ordering, Receiving, and Storing Medication
The first step to ensuring that your medication is safe is to ensure you are ordering from a licensed wholesaler or manufacturer. It sounds simple, and it is. Before ordering any medication, you should verify that the entity you are ordering medication through is licensed. The Drug Supply Chain Security Act (DSCSA) requires you to confirm that your authorized trading partner (ATP) is licensed. The DSCSA also requires you to receive the transaction data (transaction information (TI), transaction history (TH), and the transaction statement (TS)) from your ATP before or at the time of delivery. Also, during this stage, you must review the product to ensure that it is not suspect or illegitimate. If so, quarantine the product and follow your DSCSA Compliance Program.
Once the above is all good, check to ensure you store the medication according to manufacturer labeling. Medication can be less effective or may lose its effectiveness if it is not stored appropriately.
Note: For more information on the DSCSA, please look at our two recent blog posts, Drug Supply Chain Security Act in Pharmacy: Today and Tomorrow and Enhanced Drug Distribution Security System.
Now comes the second phase of ensuring safety, conducting inventory reviews. We recommend that pharmacies review each bottle in stock every month to see if it is nearing expiration and returning overstock. Bottles nearing expiration should be marked, typically with a sticker, to let pharmacy employees know there is less than a year remaining. This also will allow you to review your stock levels and possibly return overstock – freeing up the monies.
Pharmacy Management System
In pharmacy, we rely on computers, and, most of the time, they make our lives easier and less complicated by allowing us to fill prescriptions quickly and safely. But you must ensure that your Pharmacy Management System is properly set up to run Prospective Drug Utilization Reviews (ProDUR) with information about the patient.
- Potential and actual adverse effects
- Therapeutic duplication
- Drug-disease interactions and contraindications
- Incorrect dosage, frequency, or duration of treatment
- Drug allergy
- Clinical misuse or abuse
- Drug-drug interactions
- Medication appropriateness (including age and gender)
- Overutilization and underutilization of drug treatment
- Pregnancy alerts
Then when you go to fill a new prescription or refill an existing one, it will review that order against the patient’s information. If any issues appear, the pharmacist should review and override them as appropriate, counsel the patient, or contact the prescriber as necessary.
You should also review any DUR messages coming back from the PBMs when you submit a claim. This message will sometimes have additional information, especially prescription information from other pharmacies the patient may be using.
In line with the last section, you should collect information about your patients and have that information loaded into your Pharmacy Management System. This information could include the following:
- Date of Birth
- Existing medication (including OTCs and herbal supplements)
- Existing disease states
Also, this information should be reviewed yearly with the patient to ensure there have been no updates.
Prescription Intake, Review, and Pharmacist Check
In the last step, you will process, fill, and dispense the prescription. During this phase, you will input the patient’s information, select the correct drug, perform the DUR, correct any issues found during the DUR, fill the prescription, review the response from the PBM (if any), count the medication, fill the vial(s), label the vial(s). As questions arise during this phase, the pharmacist should contact the prescriber to clarify information. This phase will end with a pharmacist reviewing the prescription, making sure everything is correct, bagging the prescription, and counseling the patients as required.
What about Quality Related Events?
Stuff happens. If there is a medication error, the pharmacy manager must follow the State Board of Pharmacy requirements and review the events that led to the error, sometimes called a root cause analysis. If there was a root cause, the pharmacy manager would typically work with the pharmacy team to devise a corrective action plan to lessen the chances of a similar event.
How Can PRS Help?
PRS’s COMPLIANCETrack is a family of programs designed to help you comply with many compliance areas reviewed and required by PBMs and other entities. As it relates to Comprehensive Safe Medication Practices, the below programs are the core that every pharmacy should have in place:
These Programs provide policies, procedures, forms, and trainings to ensure that your employees know their responsibilities.
For more information about PRS Pharmacy Services’ Pharmacy Compliance offerings, click on the following link, COMPLIANCETrack, or call PRS at 1-800-338-3688. Join the thousands of independent pharmacies that currently utilize the benefits of PRS’s Compliance Programs.